FDA-Device2016-09-28Class II
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
EKOS Corporation
Hazard
The recalling firm identified ten devices which were distributed and could potentially be non-compliant. These devices potentially underwent a routine manufacturing test with non-compliant parameters, which may result in a small blister in the epoxy over transducers in the treatment zone. It is not known at the time the recall was initiated whether the non-compliant test parameters, or presence of the blisters, adversely affect operation of the device.
Sold states
Three international consignees - Germany, New Zealand and Taiwan
Affected count
10 units
Manufactured in
11911 N Creek Pkwy S, Bothell, WA, United States
Products
EkoSonic Endovascular Devices EKOS Intelligent Drug Delivery Catheter
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2854-2016Don't want to check this manually?
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